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Clinical Trials/NCT01252147
NCT01252147
Completed
Not Applicable

Inter-rater and Intra-rater Reliability Study of the Global Eyelash Assessment Scale for Assessment of Overall Eyelash Prominence

Allergan0 sites68 target enrollmentDecember 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy Volunteers
Sponsor
Allergan
Enrollment
68
Primary Endpoint
Overall Inter-Rater Reliability of Assessing Overall Eyelash Prominence Using the Japanese Global Eyelash Assessment Scale (GEA-J) at Day 1
Status
Completed
Last Updated
13 years ago

Overview

Brief Summary

This study will evaluate the inter-rater and intra-rater reliability of the Global Eyelash Assessment (GEA) scale with photonumeric guide in Japanese subjects.

Registry
clinicaltrials.gov
Start Date
December 2010
End Date
December 2010
Last Updated
13 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Allergan
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Able and willing to remove all eye makeup and facial jewelry during study

Exclusion Criteria

  • Permanent eyelid makeup or eyelash implants of any kind
  • Eyelash tint or dye application within 2 months
  • Eyelash extensions within 3 months

Outcomes

Primary Outcomes

Overall Inter-Rater Reliability of Assessing Overall Eyelash Prominence Using the Japanese Global Eyelash Assessment Scale (GEA-J) at Day 1

Time Frame: Day 1

Inter-rater agreement (among raters) of the GEA-J scores (1=minimum,2=moderate, 3=marked, 4=very marked) to assess eyelash prominence was evaluated using Kendall's coefficient of concordance (Kendall's W). Each of 7 raters who scored 68 subjects' eyelashes using GEA-J Scale with photonumeric guide at 2 different time points at day 1. The overall inter-rater agreement for Kendall's W for all raters combined was estimated based on the average of the scores from those 2 different time points. The degree of agreement of the point estimates of Kendall's W was interpreted according to the reference range scale that was pre-defined as: \<=0: poor, 0.00-0.20: slightly, 0.21-0.40: fair, 0.41-0.60: moderate, 0.61-0.80: substantial, 0.81-1:00: almost perfect. The 95% confidence interval for Kendall's W is provided.

Overall Intra-Rater Reliability of Assessing Overall Eyelash Prominence Using the Japanese Global Eyelash Assessment Scale (GEA-J) at Day 1

Time Frame: Day 1

Intra-rater (within raters) agreement of the GEA-J scores (1=minimum, 2=moderate, 3=marked, 4=very marked) to assess eyelash prominence was evaluated by weighted Kappa statistics. Weighted Kappa statistics were calculated for each of 7 rater who evaluated 68 subjects using GEA-J scale with photonumeric guide, assessing agreement between 2 different time points at day 1. The overall intra-rater agreement for Kappa statistics for all raters combined was estimated by pooling Kappa statistics for each rater using a chi-square statistic. The degree of agreement of the point estimates of Kappa statistics was interpreted according to the reference range scale that was pre-defined as: \<=0: poor, 0.00-0.20: slightly, 0.21-0.40: fair, 0.41-0.60: moderate, 0.61-0.80: substantial, 0.81-1:00: almost perfect. The 95% confidence interval for Kappa statistics is provided.

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